The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp’s Web site. FDA recommends that consumers who are currently using Melanotan II stop using this product and consult their health care provider if they have experienced any adverse events that they suspect are related to its use.

“This product is being mislabeled, marketed and sold illegally as a preventative against skin cancer and as a tanning agent,” said Steven Galson, M.D., M.P.H. director of FDA’s Center for Drug Evaluation and Research. “Protecting the public from unapproved products such as this that make unsubstantiated claims and may pose a health risk is a top priority at the FDA.”

Melanocorp, Inc. advertises the product Melanotan II on its Web site as an injectable tanning product, with additional claims that it is effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). These claims cause Melanotan II to be classified as a drug under the Federal Food, Drug and Cosmetic Act, as well as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses. This product does not have an approved new drug application, and the product’s Web site makes false and misleading statements. The product’s introduction and delivery into interstate commerce, therefore, violates federal law. The risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs. The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider.

Issuance of this Warning Letter is consistent with FDA’s focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions.

Consumers and health care providers should notify FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, FDA’s voluntary reporting program, by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/report.htm.